BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.5MM TI RECON SCREW WITH T25 STARDRIVE 90MM-STERILE

    MDR report key: 6658284 · Received June 21, 2017

    Report

    Report Number
    3000270450-2017-10201
    Event Type
    Injury
    Date Received
    June 21, 2017
    Report Date
    May 24, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HSB
    PMA / PMN Number
    K040336
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    WEIGHT NOT AVAILABLE FOR REPORTING. DATE OF MISALIGNMENT IS NOT KNOWN. (B)(4). IT IS NOT KNOWN IF REVISION SURGERY TOOK PLACE ON (B)(6) 2017 AS SCHEDULED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NON-STERILE 04.003.028 / 9874618. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE:17.MAR.2016. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. MANUFACTURING LOCATION: (B)(4). SUPPLIER: (B)(4). MANUFACTURING DATE: 04.APR.2016 EXPIRY DATE: 01.MAR.2026. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    CONCOMITANT DEVICE REPORTED: EXPERT A2FN NAIL (PART # 04.009.253S, LOT # 9465451, QUANTITY 1).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2017, A WEEK AFTER IMPLANT, IT WAS CONFIRMED THROUGH X-RAYS THAT THE TWO HIP SCREWS WERE OUT OF BOUNDS AND DID NOT GO THROUGH THE SCREW HOLE. IT COULD NOT BE DETERMINED WHEN THE HIP SCREWS HAD BEEN OUT OF BOUNDS. THE SURGERY FOR SCREW REPLACEMENT IS SCHEDULED ON (B)(6) 2017. IT IS NOT KNOWN IF THIS PROCEDURE TOOK PLACE AS SCHEDULED. THIS REPORT IS FOR ONE (1) 6.5 MM RECON SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438732 6.5MM TI RECON SCREW WITH T25 STARDRIVE 90MM-STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES SELZACH 9894249

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention